Mesalamine Delayed-Release Tablets — Class II drug recall D-0862-2020
Terminated recall by Teva Pharmaceuticals USA, reported 2020-03-11, distributed nationwide. Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testi
| Recall number | D-0862-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Parsippany, NJ, United States |
| Recall initiated | 2020-02-20 |
| Classified | 2020-03-02 |
| Reported by FDA | 2020-03-11 |
| Terminated | 2020-10-06 |
| Distributed | Nationwide (US) |
| Quantity | 3,695 bottles |
| Reason classes | specification failure |
| NDC | 00591-2245, 00591-2245-22 |
| Lot numbers | 1342500A |
| Expiration dates | 2020-10 |
Product
Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; NDC 0591-2245-22.
Reason for recall
Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0862-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.